Clinical Project Manager at Kuros Biosciences - New York City, New York Clinical Project Manager - Kuros Biosciences

Clinical Project Manager

Kuros Biosciences

Location: New York City, New York, USA

Category: Healthcare

Salary: 80,000 - 120,000 USD / yearly

Full-time

Job Description

The Clinical Project Manager will report to the Senior Director of Clinical Affairs and manage Clinical Research Associates as part of the Clinical Affairs Team. This remote position, available within 80 miles of a major U.S. airport, requires a highly organized individual with strong communication skills and attention to detail. The role involves leading clinical studies in compliance with Good Clinical Practice (GCP), local regulations, and company standards.

Responsibilities

  • Clinical trial data management and support of sites.
  • Assist in the development of CRFs and other study related documents.
  • Independently review eCRFs and reports, ensuring that clinical trials are being conducted in accordance with protocols, GCP, ICH, SOP's and regulations (FDA/DEA).
  • Review and approve reports from site qualification visits, site monitoring visits and study close out visits. Provide support to the site staff in case of audits or inspections. Following up with clinical sites to ensure accuracy, integrity and completeness of the study data.
  • Managing regulatory documents and maintaining regulatory compliance, reviewing data entered into the EDC.
  • Oversee the contracting and management of vendors and ensure expectations are met.
  • Training of site personnel, identifying study related issues and escalating as needed.
  • Ensure the set up and maintenance of project plans are in compliance with company policies and timelines.
  • Identify, address and/or escalate study related risks, issues, mitigations, and opportunities for improvements.
  • Review and track clinical invoices.
  • Engage with Key Opinion Leaders (KOLs) in the fields of medicine or research.
  • Stay informed on the latest scientific research and clinical data relevant to Kuros Biosciences.
  • Ability to travel between 15% of the time.

Qualifications

  • Bachelor's Degree in a life sciences field, (science related discipline preferred).
  • Minimum 3 years medical device industry experience. Experience in managing clinical trials whether by Sponsor and/or CRO, and on-site monitoring experience is required.
  • The highest ethical standards, specifically surrounding protected medical information and clinical research.
  • Working knowledge of relevant clinical regulations and industry standards including Good Clinical Research Practice, ICH, ISO, FDA and the MedTech EU Code of Practice.
  • Excellent verbal and written communication skills (protocols, reports, correspondence, etc.)
  • Proficiency in Word, Excel, PowerPoint, SharePoint, Microsoft Teams, etc.

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